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beatson west of scotland cancer centre
beatson west of scotland cancer centre

... as an 18 bed 5 day/week chemotherapy ward. There is also a large and busy Day Case Chemotherapy Unit comprising 36 treatment stations. The centre has its own out-patient department and a large aseptic facility for cytotoxic reconstitution. The unit has an accredited gene therapy aseptic facility. Up ...
Drug Discovery from Plants
Drug Discovery from Plants

... Abstract  Many plant-derived compounds have been used as drugs, either in their original or semi-synthetic form. Plant secondary metabolites can also serve as drug precursors, drug prototypes, and pharmacological probes. Recent developments in drug discovery from plants, including information on app ...
Institutional Review Boards and Independent Ethics Committees
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An Exploration of Ethical Issues - ScholarWorks@GVSU
An Exploration of Ethical Issues - ScholarWorks@GVSU

... consent. At the time, the focus of researchers was not on participants’ well being but on the maximization of medical knowledge on syphilis. The actions of researchers were not regulated as it is today because of the lack of formal rules and guidelines. Informed consent became the focus of law and e ...
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... • (n = 308) - IFN-β-1b comparison • (n = 308) - IFN-β-1a IM comparison • (n = 267) - IFN-β-1a SC comparison ...
Comparative Effectiveness Research: What Kind of Studies Do We
Comparative Effectiveness Research: What Kind of Studies Do We

... address whether an intervention can work under ideal circumstances. Early-phase clinical trials and applications to the Food and Drug Administration for licensure, including studies conducted or supported directly by the pharmaceutical industry, tend to fall into this category. Randomized trials eva ...
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Combined Phase Studies
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Interface Terminology - Vanderbilt University Medical Center
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... Patients > 70 years of age should be considered for treatment with capecitabine at 75% of the full dose but, in light of differences in standard practice between sites, this will be left to the discretion of the Investigator depending on the fitness of the individual patient. The decision not to dos ...
Chapater 12 - IND/NDA/ANDA/AADA
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... might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population. In this case, the physician is both the sponsor and investigator. Usually the investigator will cross-reference the original sponsor companies IND for the p ...
Dr. Roland E. Dolle - IGMORIS - Indian GMO Research Information
Dr. Roland E. Dolle - IGMORIS - Indian GMO Research Information

... companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Adolor undertakes no obligation to publicly update or revise t ...
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... • Carry-over effect needs wash-out period Senn S. (1993) Crossover trials in clinical research. Chichester, John Wiley ...
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... Low- to medium-dose glucocorticoids have been shown to have not only anti-inflammatory but also diseasemodifying properties in rheumatoid arthritis. The evidence for the benefit of its early use in combination with disease-modifying antirheumatic drugs underlines the need for a close evaluation of t ...
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Slide 1

... • Carry-over effect needs wash-out period Senn S. (1993) Crossover trials in clinical research. Chichester, John Wiley ...
Clinical Trial Endpoints - M
Clinical Trial Endpoints - M

... sufficient to adequately validate a surrogate for use as a primary endpoint in a Phase 3 trial. • Once validated, a surrogate may be useful for future studies of medicines, particularly those with same mechanism of action *This aspect contributed to the controversy surrounding the use of skeletal mu ...
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... Values are presented as mean change from baseline ± standard error (SE). * p< 0.05 based on ANCOVA controlled for Mini-Mental State Examination (MMSE) and baseline mean ...
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Clinical trial

Clinical trials are experiments done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial - their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.Trials can be quite costly, depending on a number of factors. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.Only 10% of all drugs started in human clinical trials become an approved drug.
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